ALMAGATE for Gastroesophageal reflux disease

Inclusion criteria

• {"criterion_text":"- Adult pregnant women (age 18-45 years) with heartburn."}

Exclusion criteria

• {"criterion_text":"- Risk pregnancy. A high-risk pregnancy is defined as one that meets any of the following criteria: - Morbid obesity (BMI ≥ 40) - History of miscarriage (two or more previous miscarriages not performed voluntarily) - History of cervical insufficiency (history of the cervix's inability to carry a pregnancy to term) - Previous chromosomal abnormality (inherited fetal abnormalities) - Previous ectopic pregnancy - Previous gestational trophoblastic disease - Previous premature birth - Endocrinopathies (disorders of the endocrine gland, for example, hyper/hypothyroidism, prolactinoma, adrenal gland disorders) - Cardiovascular risk (WHO class III) - Twin pregnancy - Maternal infection diagnosed during pregnancy - Rh (D) isoimmunization and others - Current severe mental illness (psychotic disorders that occur continuously or episodically during pregnancy) two years or older). - Severe anemia (hemoglobin levels below 9 g/dL or hematocrit below 25%) - Suspected fetal malformation and/or fetal genetic/chromosomal abnormality.-\t - History of perinatal death. - Alcohol or other drug dependence. - Multiple gestations with three or more fetuses. - Threatened preterm labor. - Premature rupture of membranes."}
• {"criterion_text":"- Patients with diagnosed pre-gestational hypertension (HTN>140/90)."}
• {"criterion_text":"- Patients with eclampsia and preeclampsia"}
• {"criterion_text":"- Patients with pregestational diabetes mellitus or poorly controlled or corrected gestational diabetes with diet and insulin"}
• {"criterion_text":"- Lack of informed consent."}
• {"criterion_text":"- criteria for discontinuation and premature withdrawal"}
• {"criterion_text":"- Presence of undiagnosed gastrointestinal or rectal bleeding, severe hemorrhoidal syndrome*, or chronic digestive diseases accompanied by persistent pre-gestational diarrhea. *Severe hemorrhoidal syndrome is defined as: characterized by the presence of hemorrhoids in an advanced stage with intense symptoms and associated complications: - Intense and persistent pain, especially if there is hemorrhoidal thrombosis. - Heavy, intermittent, or constant bleeding, which can lead to anemia. - Irreducible hemorrhoidal prolapse, that is, when the hemorrhoids remain permanently outside the anus and cannot be manually reduced. - Thrombosis or ulceration, which can lead to increased inflammation, infection, and necrosis in severe cases. - Significant impact on quality of life, with difficulty sitting, defecating, or performing daily activities. - In these cases, medical treatment is usually insufficient, and surgery is considered the main option, such as hemorrhoidectomy or less invasive techniques such as rubber band ligation or transanal hemorrhoidal dearterialization (THD)."}
• {"criterion_text":"- Other circumstances or difficulties that, in the researcher's judgment, may increase the risk to the subject or reduce the chances of obtaining satisfactory data to achieve the objectives of the study."}
• {"criterion_text":"- Patient unable to give consent, or patient of consenting age but under guardianship, or vulnerable patients."}
• {"criterion_text":"- Patients must be in the first trimester of pregnancy; those eligible cannot be included until week 13+0 of pregnancy (all pregnancies before or at 13.0 weeks of gestation are excluded). Pregnancy is dated by measuring the CRL distance in the first trimester or, failing that, by the date of the last menstrual period."}
• {"criterion_text":"- Being participating or having participated in another clinical trial in the 6 months prior to the inclusion in this study."}
• {"criterion_text":"- Prior treatment with medications: antacids (except Almax), proton pump inhibitors (PPIs) or anti-histamine 2 blockers (anti-H2) during this pregnancy."}
• {"criterion_text":"- Hypersensitivity to almagate or any of its excipients"}
• {"criterion_text":"- Patients with Alzheimer's disease."}

Primary endpoints

• {"endpoint_text":"- Data collected at baseline and follow-up visits: Gestational diabetes","definition_or_measurement_approach":"Data collected at baseline and follow-up visits"}
• {"endpoint_text":"- Data collected at baseline and follow-up visits: Hypertensive states of pregnancy (Gestational hypertension (HT), Pre-eclampsia, Eclamps)ia","definition_or_measurement_approach":"Data collected at baseline and follow-up visits"}
• {"endpoint_text":"- Data collected at the delivery visit: Abruptio placentae","definition_or_measurement_approach":"Data collected at the delivery visit"}
• {"endpoint_text":"- Data collected at the delivery visit: Immediate postpartum haemorrhage","definition_or_measurement_approach":"Data collected at the delivery visit"}
• {"endpoint_text":"- Data collected at the delivery visit: Perinatal mortality (Foetal death, Neonatal mortality)","definition_or_measurement_approach":"Data collected at the delivery visit"}
• {"endpoint_text":"- Data collected at the delivery visit: Maternal mortality","definition_or_measurement_approach":"Data collected at the delivery visit"}
• {"endpoint_text":"- Data collected at the delivery visit: Low birth weight","definition_or_measurement_approach":"Data collected at the delivery visit"}

Secondary endpoints

• {"endpoint_text":"- Type of delivery: Vaginal delivery, Instrumental, Caesarean section","definition_or_measurement_approach":"Type of delivery recorded at delivery visit"}
• {"endpoint_text":"- Birthing start: Spontaneous , Induced, Planned Caesarean section","definition_or_measurement_approach":"Onset of labour recorded (spontaneous, induced, planned caesarean)"}
• {"endpoint_text":"- Weight and length of the newborn (NB)","definition_or_measurement_approach":"Anthropometric measures of newborn at birth"}
• {"endpoint_text":"- Gestational age (GA) of NB at delivery: GA <37 weeks: pre-term NB, GA 37-42 weeks: full-term NB, GA >42 weeks: post-term NB","definition_or_measurement_approach":"Gestational age classification at delivery"}
• {"endpoint_text":"- NB APGAR","definition_or_measurement_approach":"APGAR score recorded for newborn"}
• {"endpoint_text":"- Date of delivery: identification of pre-term, full-term, and post-term delivery.","definition_or_measurement_approach":"Delivery date used to classify term status"}
• {"endpoint_text":"- Physical examination will include a complete head and neck examination, a cardiovascular, respiratory, abdominal and a complete neurological examination, including state of consciousness, motor system, primitive reflexes, osteotendinous reflexes, muscle tone, and sensitivity","definition_or_measurement_approach":"Standard physical and neurological examinations recorded per visit"}
• {"endpoint_text":"- The total score of the ASQ-3™ questionnaire taken at 24 months of age will be assessed, either as the score in each of the five different areas comprising this questionnaire: communication, gross motor, fine motor, problem solving and personal-social.","definition_or_measurement_approach":"ASQ-3™ questionnaire administered at 24 months; total and domain scores assessed"}
• {"endpoint_text":"- The efficacy of almagate as antacid will be assessed at each follow-up visit referring to each episode of heartburn/reflux by the general impression of the physician, on the one hand, and of the patient, on the other hand, classifying it as \"very good\", \"good\", \"acceptable\", \"poor\", \"very poor\" after the question \"How would you classify your experience with the use of almagate for the treatment of heartburn/reflux?\".","definition_or_measurement_approach":"Physician and patient global impression rated on a 5-point scale at each follow-up episode"}
• {"endpoint_text":"- Patient satisfaction will be assessed at the follow-up visits through her response on the degree of agreement with the statement “I am satisfied with the use of almagate as antacid”, with 5 scoring options, from “completely disagree” to “completely agree” (Likert scale).","definition_or_measurement_approach":"Patient-reported satisfaction using a 5-point Likert scale at follow-up visits"}

Spain

Earliest CTIS Part Ii Submission Date

05-09-2024

Latest Decision Or Authorization Date

17-02-2026

Processing Time Days

530

Number Of Sites

14

Number Of Participants

297

Primary sponsor

Full Name

Almirall S.A.

Organisation Type

Pharmaceutical company

Country Of Registered Address

Spain